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…rejected FDA’s arguments by ruling that FDA had other alternatives, such as allowing domestically manufactured unapproved drugs to be sold to alleviate drug shortages. According to the Court: By its…
…request to the DEA for “reprocessing, including further consideration of [the appropriate] fee category.” After hearing no response for another four months, Dr. Coleman filed suit pro se in federal…
…bill.” Senate Bill 2687, now officially law in Mississippi, prohibits local governments from restricting soda size, requiring calorie counts on menus, and banning toys in kids’ meals. The law prohibits…
…of approval requirements – that is, the issues holding up approval at the 30 month date must be causally connected to the approval requirements that FDA reviewed or changed. [(Emphasis…
…in Sackett earlier this term regarding when allegedly non-final agency action can be challenged (see our previous post here), this aspect of Fox should provide additional support for companies seeking…
…even when a meeting has been scheduled. We have also noticed, in some circumstances, Offices declining to answer all of a sponsor’s questions noting that, for example, a separate pre-submission…